3D Systems Expands Orthopedic Surgical Planning Portfolio Receiving FDA Clearance for Key Ankle Indications

3D Systems Inc.

In This Article:

  • New TOTAL ANKLE Patient-Matched Guides pair with Smith+Nephew’s Total Ankle replacement solution, designed to help surgeons save time and ensure accuracy while performing fewer steps than standard instrumentation

  • FDA clearance expands 3D Systems’ leadership in supporting orthopedic surgeons, with surgical planning experience now exceeding 175,000 cases

  • 3D Systems engineers and manufactures custom, patient-specific orthopedic solutions leveraging its VSP surgical planning workflows that include market-leading medical 3D printing technologies

  • Furthers company strategy of accelerated expansion in orthopedics through 3D printing of patient-specific surgical solutions and customized workflows, a market anticipated to reach $5.3 billion by 20323

ROCK HILL, S.C., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Today, 3D Systems (NYSE:DDD) announced the Food and Drug Administration (FDA) has provided 510(k) clearance for TOTAL ANKLE Patient-Matched Guides to be used with Smith+Nephew’s SALTO TALARIS? Total Ankle Prosthesis and CADENCE? Total Ankle System. The products feature individualized pre-surgical planning and a patient-specific 3D-printed instrument set that ensures accurate implant alignment and sizing for tailored total ankle replacement surgery. The collaboration between 3D Systems and Smith+Nephew, the global medical technology company, achieved these patient-matched solutions that enable surgeons to prepare the bony anatomy of the tibia and talus for placement of implants intended to restore proper function of the ankle joint. These patient-matched guides are engineered and manufactured using 3D Systems’ VSP? surgical planning solutions that combine best-in-class digital workflows with the industry’s broadest additive manufacturing portfolio of printers and materials.

3D Systems’ personalized solutions are designed to enable surgeons to capitalize on benefits such as performing the operation with less procedural steps, shorter operating room (OR) time,1-2 and less intraoperative x-ray radiation2 as compared to procedures using standard non-patient-specific instruments. Ben Johnson, 3D Systems’ vice president, portfolio & regulatory, commented, “With over 25 years of experience, our solutions have supported more than 175,000 patient-matched cases with the goal of improving surgical outcomes and the overall patient experience. Our VSP surgical planning workflow including the expertise of our biomedical engineers, our Selective Laser Sintering technology, and our DuraForm? ProX? PA materials is a differentiator in the market and was instrumental in the success of this program within a short timeframe.”